Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

The aim of this Phase 2 study is to investigate the efficacy and safety of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) infusion in patients undergoing VATS (Video-Assisted Thoracoscopic Surgery) or RATS (Robotic-Assisted Thoracoscopic Surgery) resection of Stage I-II non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT07276789

Run by

Integro Theranostics

People needed

35

Starts

2025-12-08

Expected to finish

2026-09-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
• Are scheduled to undergo surgical thoracoscopy and resection of the lung.
• If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to LS301-IT administration, as well as using a medically acceptable form of contraception (eg, hormonal birth control, double-barrier method) or abstinence.
• Ability to understand the requirements of the study

You may not qualify if…

• Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
• History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other contrast agents.
• Patients with impaired renal function
• History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities
• History of radiation therapy to the chest
• Total bilirubin level >1.5 times upper limit
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN)
• Patient is pregnant or breast feeding

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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